InfuScience a subsidiary of Bioscrip
Form 483 issued May 15, 2015 · Mount Pleasant, South Carolina
- Inspection
- May 12 – May 15, 2015
- Investigators
- Carmen Y. Kelly· Viviana Matta
- Observations
- 10
- Pages
- 4
- FEI number
- 3011515831
In short: On May 15, 2015, FDA issued a Form 483 with 10 observations to InfuScience a subsidiary of Bioscrip in Mount Pleasant, South Carolina (FEI 3011515831) after an inspection that ran May 12 – May 15, 2015. The investigators were Carmen Y. Kelly and Viviana Matta. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 7 of 10 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of all written and oral complaints regarding a drug…
- 02
Clothing ofpersonnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
! .....rIJ Aseptic processing llr~~s~re d~ficient regarding th~ ~y~te~ f~r cleoolngand dlsi}lfecthtg the t:oom atid e{jiilprnei\i…
This inspection in context
Carmen Y. Kelly
1 document · 2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in South Carolina.
The firmInfuScience a subsidiary of Bioscrip history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at InfuScience a subsidiary of Bioscrip?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected InfuScience a subsidiary of Bioscrip?
Carmen Y. Kelly and Viviana Matta are named on this Form 483, for the inspection of May 12 – May 15, 2015. Each investigator has a profile showing what they cite most.
When was InfuScience a subsidiary of Bioscrip inspected by FDA?
The inspection ran May 12 – May 15, 2015, and the Form 483 is dated May 15, 2015.
How do I get the full Form 483 for InfuScience a subsidiary of Bioscrip?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.